MedTech Europe in the headlines – Summer 2026

Posted on 11.09.2026

Summer media coverage highlighted MedTech Europe’s leadership across key policy debates, including the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) revisions, health technology assessment, digital regulation, international trade, and most recently the Public Procurement Act.

EU’s AI Act climbdown raises stakes for MDR revisions

MDR/IVDR reform remained at the centre of media attention throughout the summer. Euractiv highlighted Commissioner Olivér Várhelyi’s remarks at MedTech Europe’s CEO Summit, where he described revision of the framework as unavoidable. The outlet also covered MedTech Europe’s joint position paper advocating a more proportionate lifecycle approach to regulation. Meanwhile, POLITICO reported the sector’s cautious optimism regarding the reform process, quoting CEO Oliver Bisazza and Director of Regulatory Affairs Petra Zoellner on the expected legislative timeline. Following the publication of Parliament’s draft report, MedTech Europe stressed that “simplification and patient safety are not in tension”, as reported by POLITICO.

Medtech Insight‘s review of H1 2026 draws heavily on MedTech Europe‘s positions, from our December 2024 launch survey to our position paper on the revisions, and quotes our association describing the MDR/IVDR revisions as our “immediate priority” and “the right vehicle to close the coherence gap” left by the AI Act agreement.

Europe’s new Joint Clinical Assessments: Harmonization or just more hoops?

As the first two devices enter the new EU-wide health technology assessment pathway, experts say they want to know more about how devices are selected, what data will be demanded, and how national authorities will leverage the output. Jesús Rueda Rodríguez, MedTech Europe’s Director General of industrial affairs and strategies, highlighted in an interview with MedTech Strategist the potential of Joint Clinical Assessments to help reduce market fragmentation across Europe.

Commission adds new medical device types to records

The European Commission has expanded its list of well-established technologies (WET), adding around 55 medical device categories with long-established safety and performance records. MedTech Europe told Euractiv the measures would support continued device availability but urged broader legislative reform of the Medical Device Regulation.

Digital Omnibus: A joint appeal by EFPIA, MedTech Europe, and other associations

Around thirty European industry associations, including MedTech Europe for the medical technologies sector, have jointly addressed an open letter to EU Member State representatives calling for measures to simplify the digital framework. This framework is the subject of the Digital Omnibus package of measures currently being finalised by the European institutions, as published by Notiziario Chimico Farmaceutico.

Tariffs meant to reshore medtech would send it offshore, industry tells USTR

On international trade, MedTech Europe told Medtech Insight that tariffs imposed on medical technologies would affect not only European exporters, but also US manufacturers, healthcare providers, laboratories and patients that depend on stable and predictable supply chains.

EU Project Will Digitize Conformity Assessment To Free Up Manufacturer Resources

Medtech Insight reported that Team-NB and MedTech Europe joined forces on a project to digitize MDR and IVDR conformity assessment procedures, backed by €4m in funding, with the European Commission hoping the initiative will help promote a more innovative and competitive medtech industry.

FDA Backs PFAS In Medical Devices As Europe Moves To Ban Them And Suppliers Offer Alternatives

As reported by Medtech Insight, FDA has reaffirmed that fluoropolymers like PTFE remain safe and irreplaceable in devices, but this US reprieve offers little shelter from an EU REACH restriction on track for 2027 adoption, one that MedTech Europe warns could still hit availability of endoprostheses, vascular grafts, cardiovascular patches, sutures, hernia mesh and endoscopes even with derogations in place, pushing manufacturers toward PFAS-free alternatives regardless.

Surgical robots deliver – but who pays?

Robotic-assisted surgery can improve patient outcomes, shorten recovery times and ease physical strain on surgeons while helping hospitals use their capacity more efficiently, policymakers said at a roundtable on the technologyʼs future. Yet, as Laura Hampunen of MedTech Europeʼs Robotic-Assisted Surgery Sector Committee told Euractiv, access and implementation remain uneven across Europe.

United States Medical Devices Manufacturing

President Donald Trumpʼs second-term trade policies and global tariffs, multinational medical device companies have accelerated US manufacturing investment as a key strategy to negotiate tariff exemptions and mitigate supply chain risks. Business Online highlighted that medical devices remain subject to tariffs by the US despite calls from trade associations AdvaMed and MedTech Europe, which have warned continued tariffs on the sector will negatively impact patient care and healthcare system resilience in the US.

It’s Public Procurement Act day

As the Commission unveils its Public Procurement Act, alongside the Innovation Act, the medtech sector is warning that a proposal to prioritize “Made in Europe” products in public tenders as part of the EUʼs overhaul of its public procurement rules could hurt the price and accessibility of medical devices in Europe. “It really is a red flag for me personally,” Oliver Bisazza, CEO of MedTech Europe, told Politico’s Morning Health Care. “We would rather Europe maintain its long‑standing approach of open borders, open trade, free trade, and being the bastion of that in the world, rather than joining the same protectionist tendencies as so many other governments.”